Implications of ICS withdrawal in the real-life management of COPD

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41925
• EU PAS number:
  EUPAS30851
• Study ID:
  41925
• Official title and acronym:
  Implications of ICS withdrawal in the real-life management of COPD
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This will be a retrospective study using electronic medical records and linked COPD questionnaire data from the Optimum Patient Care Research Database (OPCRD). The sutdy will evaluate the effect of ICS cessation in patients with confirmed COPD, managed in a primary care, “real-life” setting. Specifically, it will compare the exacerbation rates and lung function of patients who stop ICS therapy to those who continue on triple therapy.
• Study status:
  Finalised

Research institutions and networks

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 30/08/2019

Actual: 03/09/2019

Study start date

Planned: 02/09/2019

Actual: 10/09/2019

Data analysis start date

Planned: 01/10/2019

Actual: 02/12/2019

Date of final study report

Planned: 13/01/2020

Actual: 26/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable